CALMATROL- diphenhydramine capsule

Calmatrol by

Drug Labeling and Warnings

Calmatrol by is a Animal medication manufactured, distributed, or labeled by Goldman Pharmaceutical Group Inc, Goldman Pharmaceutical Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

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Active ingredient (in each capsule)	Purpose
Diphenhydramine HCl 25 mg	Antihistamine

INDICATIONS & USAGE

Uses

• for the relief of occasional restlessness, hyperactivity and destructive behavior
• for the relief of anxiety associated with noise, change of environment, loneliness and stress

WARNINGS

Warnings

Do not use with any other product containing diphenhydramine

• ask a veterinarian before use if your dog has any chronic illnesses
• ask a veterinarian or pharmacist if your dog is on any other medication before use
• keep out of reach of children in case of overdose contact poison control center immediately
• stop use and contact veterinarian if symptoms persist for more than 72 hours
• do not use on dogs under 26 pounds

DOSAGE & ADMINISTRATION

Directions

• give 1 to 2 capsules every 8 hours as needed
• for dogs between 26 to 50 pounds
• do not give more than 3 doses within any 24 hour period

STORAGE AND HANDLING

Other information

• store at room temperature 20 - 25 C (66 - 78 F)
• protect from moisture
• see end flap for expiration date and lot #

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Inactive Ingredients

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch

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Questions or Comments

800.981.7642
petsotc.com

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Distributed by
Goldman Pharmaceutical Group Inc.
Holbrook, NY 11741

Tamper-evident : Do not use if carton is open or blister unit is broken or torn

MADE IN AMERICA

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton

pet otc™
over the counter

Calmatrol®
(Diphenhydramine HCl, 25mg) Antihistamine

HELPS TO
RELIEVE:
Anxiety
Hyperactivity
Destructive behavior

26 - 50 lbs
20 CAPSULES

MADE IN THE USA

Highly recommended by
veterinarians

NDC: 72087-022-20

INGREDIENTS AND APPEARANCE

CALMATROL 
diphenhydramine capsule

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 72087-022(NDC:0904-2035)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLPARABEN (UNII: 3QPI1U3FV8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STARCH, CORN (UNII: O8232NY3SJ)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color	PINK (pink)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	44;107
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72087-022-20	20 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		03/01/2019

Labeler - Goldman Pharmaceutical Group Inc (080389804)

Registrant - Goldman Pharmaceutical Group, Inc. (080389804)

Establishment
Name	Address	ID/FEI	Business Operations
Goldman Pharmaceutical Group, Inc.		080389804	REPACK